Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study

NCT02637804 | Completed Results

• 1 other identifier: JP-MKTG-201512
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (9)

• Pain and Foreign Body Sensation

  Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

  1 week

• Itching Sensation on Removal

  Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

  1 week

• Red Eye Sensation

  Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation

  1 week

• Dryness

  Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.

  1 week

• Comfort

  Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).

  1 week

• Vision

  Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).

  1 week

• Handling

  Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.

  1 week

• Lens Preference - Stenfilcon A/Narafilcon A (Group 1)

  Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).

  1 week

• Lens Preference - Stenfilcon A/Delefilcon A (Group 2)

  Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).

  1 week

Secondary Outcomes (15)

• Lens Fit - Horizontal Centration

  Baseline

• Lens Fit - Horizontal Centration

  1 week

• Lens Fit - Vertical Centration

  Baseline

• Lens Fit - Vertical Centration

  1 week

• Lens Fit - Post-blink Movement

  Baseline

Study Arms (2)

stenfilcon A vs narafilcon A (Group 1)

ACTIVE COMPARATOR

Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.

Device: stenfilcon A; Device: narafilcon A

stenfilcon A vs delefilcon A (Group 2)

ACTIVE COMPARATOR

Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.

Device: stenfilcon A; Device: delefilcon A

Interventions

stenfilcon A DEVICE

contact lens

stenfilcon A vs delefilcon A (Group 2); stenfilcon A vs narafilcon A (Group 1)

narafilcon A DEVICE

contact lens

stenfilcon A vs narafilcon A (Group 1)

delefilcon A DEVICE

contact lens

stenfilcon A vs delefilcon A (Group 2)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is over 18 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
• Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
• Can achieve a distance visual acuity of 20/30 or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter.
• Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
• Is willing to comply with the wear schedule.
• Is willing to comply with the visit schedule

You may not qualify if:

• \- A person will be excluded from the study if he/she:
• Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
• Has a spectacle cylinder ≥1.00D of cylinder in either eye.
• Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
• Has contact lens best corrected distance vision worse than 20/25 in either eye
• Presence of clinically significant (grade 2-4) anterior segment abnormalities
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
• Slit lamp findings that would contraindicate contact lens wear
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• Has aphakia, keratoconus or a highly irregular cornea.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director, Professional Service
• Organization: CooperVision Inc.

Taku.Muraoka@jp.coopervision.com

+81 3 5449 6619

Study Officials

• Yuji Kodama, MD, PhD

  Director, Kodama Eye Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 22, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 23, 2017
• Results First Posted: October 23, 2017

Record last verified: 2017-09